FDA UDI
In Commercial Distribution
🇺🇸 United States
SteriChek® Blood Leak Reagent Strips
DI: 00851575007105
·
Model: 812014
·
HACH COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
60
Basic Information
- Brand Name
- SteriChek® Blood Leak Reagent Strips
- Primary DI
- 00851575007105
- Version / Model
- 812014
- Catalog Number
- 812014
- Company Name
- HACH COMPANY
- Labeler DUNS
- 091381780
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 60
- Record Status
- Published
- Publish Date
- 2016-10-28
- Public Version
- 4
- Public Version Date
- 2018-09-12
- Public Version Status
- Update
- Public Device Record Key
- ed6ed2cf-ea2f-4689-bb2c-a06c8133314c
Device Description
Reagent test strips used to test for the presence of blood in dialysate fluid during the hemodialysis procedure.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FJD | Detector, Leak, Blood | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32128 | Haemodialysis system blood leak detector | An electrically-powered integral unit of a haemodialysis system that detects blood leaks in the effluent side of the dialysate within the system and sounds an alarm if there is blood detected on this non-blood side. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851575007105 | GS1 | ||||
| Unit of Use | 00851575007099 | GS1 |
Customer Contacts
- Phone
- 1-970-278-4951
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042322 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 0.2 | Inch | |
| Length | 3.25 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
- Type
- Storage Environment Temperature
- Temperature Range
- 60 – 90 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 60 – 90 Degrees Fahrenheit